方雪光, 张启明, 凌大奎, 宋育文. 国产醋酸甲地孕酮的质量研究:6-羟基-6-甲基-17α-乙酰氧基黄体酮差向异构体的分离与鉴定J. 药学学报, 1986, 21(8): 613-617.
引用本文: 方雪光, 张启明, 凌大奎, 宋育文. 国产醋酸甲地孕酮的质量研究:6-羟基-6-甲基-17α-乙酰氧基黄体酮差向异构体的分离与鉴定J. 药学学报, 1986, 21(8): 613-617.
FANG Xue-Guang, ZHANG Qi-Ming, LING Da-Kui , SONG Yu-Wen, . STUDIES ON THE PURITY OF CHINESE MEGESTROL ACETATE: SEPARATION AND IDENTIFICATION OF EPIMERIC ISOMERS OF 6-HYDROXY-6-METHYL-17α-ACETOXY-PROGESTERONEJ. Acta Pharmaceutica Sinica, 1986, 21(8): 613-617.
Citation: FANG Xue-Guang, ZHANG Qi-Ming, LING Da-Kui , SONG Yu-Wen, . STUDIES ON THE PURITY OF CHINESE MEGESTROL ACETATE: SEPARATION AND IDENTIFICATION OF EPIMERIC ISOMERS OF 6-HYDROXY-6-METHYL-17α-ACETOXY-PROGESTERONEJ. Acta Pharmaceutica Sinica, 1986, 21(8): 613-617.

国产醋酸甲地孕酮的质量研究:6-羟基-6-甲基-17α-乙酰氧基黄体酮差向异构体的分离与鉴定

STUDIES ON THE PURITY OF CHINESE MEGESTROL ACETATE: SEPARATION AND IDENTIFICATION OF EPIMERIC ISOMERS OF 6-HYDROXY-6-METHYL-17α-ACETOXY-PROGESTERONE

  • 摘要: 用柱层析及薄层层析对国产醋酸甲地孕酮的杂质进行了分析,共分离出7个杂质点:Ⅰ1,Ⅰ2,Ⅰ3,Ⅰ4,Ⅰ5,Ⅰ6,Ⅰ7,并对其中Ⅰ3和Ⅰ4进行分离纯制及光谱分析,确定其结构为6β-羟基-6α-甲基-17α-乙酰氧基黄体酮及其差向异构体6α-羟基-6β-甲基-17α-乙酰氧基黄体酮。本文报道了薄层层析条件(硅胶GF254,展开剂:醋酸乙酯-甲苯=7:3)以及光谱鉴别的依据。

     

    Abstract: Two impurities are separated from Chinese megestrol acetate by column chromatography and thin-layer chromatography. On the basis of UV, IR, 1HNMR, 13CNMR spectroscopy and EI mass spectrometry, these two impurities were identified as 6α-hydroxy-6β-methyl-17α-acetoxy-progesterone and its epimeric isomer 6β-hydroxy-6α-methyl-17α-acetoxy-progesterone. we report here the optimal TLC conditions (silica GF254, ethyl acetate—toluene=7:3) and the spectral data.

     

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